Cleared Traditional

IMSI, VITAL CALL

K873612 · Intl. Management Services, Inc. · Physical Medicine
Nov 1987
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K873612 is an FDA 510(k) clearance for the IMSI, VITAL CALL, a System, Environmental Control, Powered (Class II — Special Controls, product code IQA), submitted by Intl. Management Services, Inc. (Lincoln, US). The FDA issued a Cleared decision on November 23, 1987, 76 days after receiving the submission on September 8, 1987. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3725.

Submission Details

510(k) Number K873612 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1987
Decision Date November 23, 1987
Days to Decision 76 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IQA — System, Environmental Control, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.3725